You will get stratey for the submission of drug product to FDA, EMA and MHRA
Top Rated
Project details
• Preparation of eCTD packages documentation per ICH and country specific guidelines for submission to FDA, EU, MHRA. Documents Required:
• Modules 1–5 of the dossier in Word or PDF per FDA and EMA pdf specification guidelines.
• Submission details: Country, MA number, company name, product name, API, etc.
• For existing eCTD lifecycles: Submission instructions
For regulatory affairs, CMC, or regulatory operations consultations, feel free to contact me.
• Modules 1–5 of the dossier in Word or PDF per FDA and EMA pdf specification guidelines.
• Submission details: Country, MA number, company name, product name, API, etc.
• For existing eCTD lifecycles: Submission instructions
For regulatory affairs, CMC, or regulatory operations consultations, feel free to contact me.
Industry
Physical SciencesLanguage
EnglishWhat's included
| Service Tiers |
Starter
$100
|
Standard
$200
|
Advanced
$1,000
|
|---|---|---|---|
| Delivery Time | 5 days | 10 days | 30 days |
Number of Revisions | 0 | 1 | 2 |
Frequently asked questions
13 reviews
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This project doesn't have any reviews.
JB
Jack B.
Apr 27, 2026
Cosmetic Label Compliance & Registration
Consistently great working with Zia. He fixed our label to meet FDA requirements and handled product listings/registration flawlessly. Reliable, knowledgeable, and easy to work with. Highly recommended.
IK
Imran K.
Mar 18, 2026
Regulatory Affairs: FDA Cosmetic Compliance
Good experience with this freelancer. I needed help ensuring my cosmetic labels weren't going to run into trouble. He did a complete gap analysis and caught a few critical things I had missed. This saved me from serious misbranding problems down the line. Very knowledgeable and easy to work with. Highly recommend!
PC
Peter C.
Mar 6, 2026
Over the Counter Drugs Approval and Registration
Always a great experience. A true expert
PC
Peter C.
Mar 5, 2026
NDC activation and OTC Product Registration
Great communication and goes above and beyond. Highly recommend
IA
Imad A.
Jan 20, 2026
Cosmetics Regulatory Review & Compliance
Zia was exceptional to work with. His regulatory expertise helped me avoid being misbranded, and he proactively identified multiple critical mistakes made by my supplier that could have caused serious compliance issues. He is highly knowledgeable in his domain, detail-oriented, and extremely thorough in his review. Communication was clear and professional throughout, and his guidance added real, tangible value to the project. I would strongly recommend him for any regulatory or compliance-relate
About Zia
Ph.D. Chemist | Regulatory | Pharma | Cosmetic | Dietary | Med Devices
100%
Job Success
Malakand, Pakistan - 1:09 pm local time
Bringing a product to market is challenging. Regulatory delays, deficient submissions, non-compliant labels, or failed audits can cost companies months of lost revenue and significant remediation expenses.
I help pharmaceutical, cosmetic, OTC drug, dietary supplement, and medical device companies navigate global regulatory requirements with confidence.
I am a PhD Chemist with 9+ years of Regulatory Affairs experience supporting manufacturers, brand owners, distributors, and investors across the United States, European Union, and United Kingdom. My expertise spans regulatory strategy, dossier preparation, compliance audits, market authorization, and post-approval lifecycle management.
Regulatory Experience
✔ 8+ ANDAs successfully delivered
✔ 15+ EU & MHRA Hybrid Applications supported
✔ 100+ Drug Master Files (DMFs) prepared, reviewed, or remediated
✔ 18+ API compliance audits conducted in accordance with ICH Q7
✔ 200+ cosmetic brands supported for FDA MoCRA, EU CPNP, and UK SCPN compliance
✔ 100+ OTC drug listings and NDC registrations completed
✔ 100+ dietary supplement and consumer health products launched successfully
Areas of Expertise
Pharmaceuticals
• ANDA, IND, NDA, MAA, and Hybrid Applications
• eCTD Publishing and CTD Modules 1–5
• CMC Documentation and Regulatory Strategy
• Drug Master Files (DMF)
• Deficiency Letter and RTR Response Support
• GMP and Inspection Readiness
• Regulatory Gap Assessments
APIs & Excipients
• ICH Q7 Compliance Audits
• Supplier Qualification Programs
• Quality Agreements
• DMF Development and Remediation
• Technical Documentation Reviews
Cosmetics (US, EU & UK)
• FDA MoCRA Compliance
• Cosmetic Product Safety Reports (CPSR)
• Product Information Files (PIF)
• CPNP & SCPN Notifications
• Ingredient Compliance Reviews
• Labeling & Claims Compliance
• Safety Data Sheets (SDS)
Dietary Supplements & Consumer Health Products
• FDA Compliance Reviews
• Structure/Function Claim Reviews
• Label Compliance
• NDI Assessments
• Ingredient Safety Evaluations
• Facility Registration Support
Medical Devices
• Regulatory Strategy
• Technical Documentation Reviews
• FDA Registration & Listing Support
• Quality System Compliance
Compliance & Quality Support
• GMP & GDP Compliance
• Internal Audits
• Supplier Audits
• CAPA Systems
• Change Control Programs
• Risk Assessments
• Regulatory Intelligence
• SOP Development
• Quality Management Systems
Why Clients Hire Me
I focus on preventing regulatory issues before they become costly business problems. Whether you need a submission-ready dossier, a compliant cosmetic launch, an FDA label review, a DMF remediation project, or an audit-ready quality system, I provide practical regulatory solutions aligned with current FDA, EMA, MHRA, and international requirements.
My goal is simple: help clients achieve faster approvals, maintain compliance, and reduce regulatory risk.
Let's discuss your project and identify the most efficient regulatory pathway for your product.
Steps for completing your project
After purchasing the project, send requirements so Zia can start the project.
Delivery time starts when Zia receives requirements from you.
Zia works on your project following the steps below.
Revisions may occur after the delivery date.
Receive documents from client - Review Compile documents in eCTD formate